This website contains a number of documents written by Destin A. LeBlanc that are critical of certain aspects of and statements in the Risk-MaPP document. Note that Mr. LeBlanc’s main issue is not with setting limits for highly hazardous activesbased on a toxicological evaluation, but rather statements in Risk-MaPP that conventional methods, such as 0.001 of a dose, are not science-based and are arbitrary when used for any actives, including those that are not highly hazardous.

To view pdf files of documents by Mr. LeBlanc critiquing Risk-MaPP, click on the links below. Note also included are documents related to EMA’s PDE version of health-based limits. The documents are listed in chronological order except for item #11.

1.Slides from Webinar “Are We Setting Limits Correctly?”, August 19, 2008. Note that this is actually a critique of a presentation by Andy Walsh, a Risk-MaPP author, on his presentation at a June 2008 ISPE meeting, which was before Risk-MaPP was officially released in September 2010.

3.Cleaning Memo of May 2009, entitled “The Science Behind Limits” discusses what we mean when we say something is “scientific”. This is relevant because one of the main assertions in Risk-MaPP about conventional ways of setting limits is that those conventional ways are “not scientifically justified”.

4. Cleaning Memo of November 2010, entitled “A Critique of Cleaning Validation Issues in ISPE’s Risk-MaPP”. This was based on my attendance at the Risk-MaPP launch meeting in Washington, DC in September 2010.

10. Cleaning Memo Addendum of October 2012, entitled “Another Critique of Risk-MaPP”11. PharmaWeb exchange in 2002between Destin LeBlanc and Andy Walsh on the question of limits: This sheds some light on the possible origin of certain concepts in Risk-MaPP. This also includes a reply made by Destin LeBlanc that was made outside the PharmWeb site.